Traditional herbal medicinal products
A MA for a herbal medicinal product may be
submitted, as for any medicinal product, through
a full application with new tests and trials, when-
ever the application refers to a new product or a
therapeutic innovation. Alternatively, for a well-
established drug (defined in Directive 99/83) a
bibliographic application may be submitted,
when safety and efficacy for a given indication,
dose and patient population are satisfactorily
described in the published literature.
There is, however, a large number of herbal pro-
ducts that, in spite of having been used for a long
time, are not supportable by data that qualify for
well-established use with recognized efficacy and
acceptable safety. The political decision was made
that, within limits, the public interest in keeping
these products in the market could outweigh impos-
ing a burden of clinical experimentation, while also
eliminating differences in requirements and regula-
tions in different MS that could cause distortions in
commerce. Thus, recently, Directive 2004/24 was
issued, which amends Directive 2001/83 and the
Community Code relating to medicinal products
for human use. This new Directive creates a cate-
gory of ‘Traditional Herbal Medicinal Products’ as
well as provides for a simplified procedure for their
MA. Even when the definition of herbal medicinal
product, herbal drug and herbal preparation are
actually the same as those mentioned above, the
Directive also allows the presence of vitamins and
minerals, if of well-documented safety, in the com-
position of herbal products, provided that their
action is ancillary with respect to the herbal ingre-
dient.
A ‘traditional herbal medicinal product’ should
comply with the following characteristics:
indication does not require the supervision by a
medical practitioner for diagnostic purposes or
for prescription or monitoring of treatment;
administration according to a specified strength
and posology;
administration exclusively by oral, external and/
or inhalatory route;
bibliographical or expert evidence to the effect
that the product itself, or a corresponding pro-
duct, has been in medicinal use throughout a
period of at least 30 years preceding the date of
the application, including at least 15 years within
the Community;data on the traditional use sufficient to prove that
the product is not harmful in the specified con-
ditions of use and the pharmacological effects or
efficacy are plausible on the basis of long-stand-
ing use and experience.The simplified procedure for registration of tradi-
tional herbal medicinal products includes full
administrative information and a complete pharma-
ceutical dossier on the assumption that the quality of
the product is independent of its traditional use.
Nonclinical data are not necessary where informa-
tion on the traditional use proves that the product is
not harmful in the specified conditions of use. How-
ever, where concerns are raised with regard to the
product’s safety, the competent authorities may ask
for additional data necessary to assess safety. The
dossier will, therefore, include a bibliographic
review of safety data, and additional data where
required, together with an expert report.
No clinical data are required provided that effi-
cacy is at least plausible on the basis of long-
standing use and experience. The dossier will
also include information on any authorization
obtained in another MS or in a third country, and
details of any decision to refuse to grant an author-
ization.
The labeling must state that the product is a
traditional medicinal product for use in specified
indications exclusively based upon long-standing
use. The same statement must also accompany any
advertisement. Furthermore, the labeling must
indicate that the user should consult a doctor if
symptoms persist or if adverse effects not men-
tioned in the labeling occur.
The Committee for Herbal Medicinal Products
(HCMP) has been given the task of preparing a list
of herbal substances, herbal preparations and com-
binations thereof to be used in traditional herbal
medicinal products. The list will contain for each
substance the indication, strength, posology, route470 CH34 MEDICINES REGULATION IN THE EUROPEAN UNION